Tag: FDA

Alembic Pharmaceuticals gets FDA approval for Toviaz generic

pallavi123- February 2, 2022

Alembic Pharmaceuticals said that it has secured tentative approval from the US Food & Drug Administration (FDA) for its abbreviated new drug application (ANDA) for ... Read More

Apellis to submit NDA for intravitreal pegcetacoplan to FDA in H1 2022

pallavi123- November 13, 2021

Apellis Pharmaceuticals said that it is on track to submit a new drug application (NDA) for its intravitreal pegcetacoplan to the US Food and Drug ... Read More

Welspun India secures FDA 510 (k) clearance for 3 Ply Surgical Masks

businessnewstoday- September 6, 2021

Welspun India Limited, a Mumbai-based home textile company, has secured 510 (k) clearance from the US Food and Drug Administration (FDA) for its 3 Ply ... Read More

Zydus Cadila gets FDA tentative approval for Sitagliptin base tablets

pallavi123- September 6, 2021

Zydus Cadila said that its subsidiary has been granted tentative approval from the US Food and Drug Administration (FDA) for its new drug application (NDA) ... Read More

Lantern Pharma bags FDA orphan drug status for LP-184 in pancreatic cancer

pallavi123- August 11, 2021

Lantern Pharma has secured orphan drug designation for its small molecule drug candidate LP-184 from the US Food and Drug Administration (FDA) for the treatment ... Read More

Octapharma gets Octagam 10% FDA approval for adult dermatomyositis

pallavi123- July 20, 2021

Octapharma USA has secured approval for Octagam 10% from the US Food and Drug Administration (FDA) for the treatment of adult dermatomyositis. The company, which ... Read More

Alkem Laboratories gets Form 483 from US FDA for St. Louis plant

pallavi123- June 19, 2021

Alkem Laboratories said that the US Food and Drug Administration (FDA) has issued Form 483 to the company with two observations. Form 483 are given ... Read More

Cipla associate Avenue Therapeutics fails to get FDA approval for IV tramadol

pallavi123- June 15, 2021

Cipla’s step-down associate firm Avenue Therapeutics has failed to get approval from the US Food and Drug Administration (FDA) for IV tramadol as an alternative ... Read More

Lupin Limited gets FDA nod for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets

pallavi123- June 7, 2021

Lupin Limited (Lupin) said it has secured approval for its Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg, from the US Food and Drug ... Read More

Glenmark gets FDA nod for Theophylline Extended-Release Tablets generic

pallavi123- June 4, 2021

Glenmark Pharmaceuticals has secured final approval from the US Food and Drug Administration (FDA) for Theophylline Extended-Release Tablets, 300 mg, and 450 mg. The Indian ... Read More